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Decision to widen access and change the funded brand of tenofovir disoproxil, and entecavir

14 May 2018

What we’re doing

We’re pleased to announce decisions to approve agreements with Teva Pharma New Zealand Limited and Novartis New Zealand Limited for the supply of tenofovir disoproxil and entecavir tablets, respectively, and to widen access to these treatments.

The funded brand of tenofovir disoproxil will change from Viread (supplied by Gilead) to Tenofovir Disoproxil Teva (supplied by Teva). Tenofovir Disoproxil Teva will be the only funded brand of tenofovir disoproxil in both the community and hospital setting from 1 November 2018. A transition period will commence on 1 June 2018 when the new brand of tenofovir disoproxil is funded.

The funded brand of entecavir will change from Baraclude (supplied by BMS) to Entecavir Sandoz (supplied by Novartis), and Entecavir Sandoz will become the only funded brand of entecavir in both the community and hospital setting. These changes will occur as soon as practicable following Medsafe registration of Entecavir Sandoz and we will notify of the listing date and transition timeframes once registration has occurred.

From 1 June 2018, the Special Authority and Hospital Restrictions for both medicines will be removed. The ‘dispense all-at-once’ (STAT) rule will also be applied in Section B for both medicines from this date.

Teva’s brand of tenofovir disoproxil is a different salt and strength to the currently funded brand of tenofovir disoproxil (Viread) but both are clinically equivalent. From 1 August 2018 prescriptions will need to be presented as the base chemical (tenofovir disoproxil 245 mg) or the new salt (tenofovir disoproxil succinate 300.6 mg).

Repeat dispensings for the Viread brand of tenofovir disoproxil will be fully subsidised where the initial dispensing was before 1 August 2018, up until the start of the sole supply period (1 November 2018).

A Brand Switch Fee will apply to tenofovir disoproxil and entecavir for three months from the commencement of the sole supply period.

Clinicians should consult with their DHB’s ‘Health Pathway’ or equivalent platform on the management of patients with hepatitis B and HIV before commencing therapy.

Any changes to the original proposal?

We indicated that we were exploring options to fund repeat dispensings for the currently listed brand of tenofovir disoproxil (Viread) up to the start of the sole supply period. We can confirm that this will occur and this is detailed below.

The ‘dispense all-at-once’ (STAT) rule will be applied to tenofovir disoproxil and entecavir from 1 June 2018 due to the significant reduction in price.

This proposal will be of particular interest to clinicians treating patients with chronic hepatitis B and:

are currently prescribed adefovir or lamivudine

are female and are of an age where they could consider having children

are considering their options for prevention of hepatitis B virus reactivation in patients who are surface antigen negative/core antibody positive.

Details about our decision

Listing of Tenofovir Disoproxil Teva

On 1 June 2018 Tenofovir Disoproxil Teva will be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:

Base chemical

Dose form and strength of base chemical

Brand

Pack size

Proposed price and subsidy

Tenofovir disoproxil

Tab 245 mg (300.6 mg as a succinate)

Tenofovir Disoproxil Teva

30

$38.10

When tenofovir disoproxil is co-prescribed with other antiretrovirals for the treatment of HIV it will continue to be included in the count of up to 4 subsidised antiretrovirals for the purposes of Special Authority SA1651.

The Teva brand of tenofovir disoproxil contains a different salt of this chemical. From 1 August 2018, new prescriptions will need to be presented as the base chemical (tenofovir disoproxil 245 mg) or the new salt (tenofovir disoproxil succinate 300.6 mg).

Listing of Entecavir Sandoz

Entecavir Sandoz is not currently registered with Medsafe, however we expect registration to occur in the next few months. A notification will then follow with all the relevant dates for listing, referencing pricing and sole supply. Once listed our standard transition timeframes will be applied.

Removal of Restrictions

From 1 June 2018 the Special Authority, Subsidy by Endorsement and Hospital Restrictions will be removed from tenofovir disoproxil (both brands) and entecavir (both brands).

Stat dispensing (dispense all at once) will apply to tenofovir disoproxil (both brands) and entecavir (both brands) from 1 June 2018.

Reference pricing and Sole Supply

Tenofovir Disoproxil

In the Community

From 1 August 2018 the subsidy for the incumbent brand of tenofovir disoproxil will be reduced, via the application of reference pricing, to the new subsidy for Tenofovir Disoproxil Teva, as follows:

Chemical and presentation

Current Brand

Pack size

Current subsidy and price

Subsidy (price)

tenofovir disoproxil tab 245 mg (300 mg as a fumarate)

Viread

30

$531.00

$38.10($531.00)

If the supplier of Viread decides not to reduce the price of Viread to match the new subsidy, a manufacturer’s surcharge will apply when Viread is dispensed. Please note that due to the salt change and to support transition, we will fully subsidise repeat dispensings of Viread where the initial dispensing was before 1 August 2018.

On 1 November 2018 the Viread brand will be delisted from Section B of the Pharmaceutical Schedule and Tenofovir Disoproxil Teva will have Sole Subsidised Supply (SSS) until 30 June 2021, meaning that it will be the only subsidised brand until 30 June 2021.

A Brand Switch Fee will apply to dispensings of tenofovir disoproxil from 1 November 2018 until 1 February 2019.

In DHB Hospitals

On 1 September 2018 the Viread brand will be delisted from the Hospital Medicines List (HML) and Tenofovir Disoproxil Teva will have Hospital Supply Status (HSS) until 30 June 2021 with a 1% Discretionary Variance (DV) limit.

Our response to what you told us

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 26 March 2018 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

Theme

Comment

Responders considered that based on the complexity of the disease treatment, treatment should only be initiated by specialist physicians (Gastroenterology, Hepatology, Infectious Disease physicians), or Hepatitis Clinical Nurse Specialists, or General Practitioners with a special interest who have completed additional training.

We note that General Practitioners are required to prescribe within their competence and capability, and that the ‘Health Pathways’ (or equivalent platform) direct clinicians to specialist services to manage the initiation of treatment and these will vary between regions.

Practitioners who prescribe these treatments do this in the knowledge that the responsibility for the clinical decision-making rests with the Practitioner. Under the Health Practitioner Competency Assurance Act failure to demonstrate reasonable care when prescribing is the domain of the relevant health professional registering body, rather than PHARMAC.

Responders requested that, in the absence of Special Authority criteria, steps are taken to provide potential prescribers with guidance on staging, commencing and stopping therapy, to ensure patient safety.

There are management tools in place via ‘Health Pathways’ or equivalent platforms to provide guidance on the diagnosis and management of hepatitis B. We note that, following blood tests confirming disease status, guidance recommends a referral to secondary care and registration with the Hepatitis Foundation.

We will provide implementation support to encourage primary care clinicians to use these pathways. We will also provide additional education resources to support hepatitis B treatment in primary care.

Responders were concerned that the salt change of tenofovir may result in some incorrect prescriptions being presented and considered that education to prescribers and pharmacists would help to mitigate this issue.

We will be communicating with prescribers and pharmacies about this change. We have also extended the available time in which repeat dispensings can be claimed for the Viread brand of tenofovir disoproxil.

Medsafe has advised that the June 2018 Prescriber Update will include an article about the equivalence of the different salts.

Responders considered that the pharmacy dispensing software should be able to claim ‘owed’ quantities for the new brand of tenofovir or entecavir as these medicines are expensive and wastage rules do not apply.

Tenofovir and entecavir are both supplied in 30 tablet packs – equivalent to a monthly prescription. Given this we consider that it would be very rare that pharmacies would have an ‘owe’ on these medicines. We note that there will be a five-month transition period from listing date (plus an additional three months’ advance notification of the possible change signalled in the consultation letter) which should provide sufficient time for pharmacies to take appropriate steps to manage stockholdings.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.